the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000, China
NCT Number: NCT07410533
This study was designed as a single-center, prospective, randomized controlled trial and included 80 patients with rosacea treated at the Department of Dermatology, Jiangsu Provincial People's Hospital. All patients received pulsed dye laser therapy (pulsed dye laser system; Cynosure (Beijing) Medical Technology Co., Ltd., China). Treatment energy was adjusted according to individual clinical responses, with no concomitant therapies administered. All patients were informed of study-related precautions and provided written informed consent prior to enrollment.
Each patient underwent a single session of bilateral facial 595-nm pulsed dye laser treatment with randomized pulse durations of 6 ms or 10 ms, using a fluence of 9-11 J/cm² and a 7-mm spot size, followed by post-treatment epidermal cooling. Skin imaging was performed at baseline and at 1 month after treatment. At 3 and 7 days post-treatment, erythema improvement, pain visual analog scale (VAS) scores, and adverse events were assessed using questionnaires. At 1 month, treatment efficacy and safety were evaluated based on erythema improvement, patient satisfaction, Clinical Erythema Assessment (CEA) score, Investigator's Global Assessment (IGA) score, Rosacea Area and Severity Index (RASI) score, skin imaging analysis, and adverse event records.
Looking for future studies?
Notify Me20 year–60 year
All sexes
Interventional
Not applicable
Nanjing, Jiangsu, 210000, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The PDL (595 nm, VBeam, Candela/Syneron, Wayland, MA) settings were: Energy range, 9-11 J/cm2[Y7.1]; spot size, 7 mm; pulse duration, 6ms; with a dynamic spray cooling device was used during this study.
The PDL (595 nm, VBeam, Candela/Syneron, Wayland, MA) settings were: Energy range, 9-11 J/cm2[Y7.1]; spot size, 7 mm; pulse duration, 10ms; with a dynamic spray cooling device was used during this study.
Time frame: From enrollment to the end of treatment at 4 weeks
Clinician's Erythema Assessment (CEA) scale Scores 0= clear Clear skin with no signs of erythema
1 = Almost clear Slight redness; almost clear 2=mild Definite redness; mild erythema 3 = moderate Marked redness; moderate erythema 4= severe Fiery redness; severe erythema
This scale assesses the average facial erythema condition over 24 hours.For CEA scoring, which were evaluated masked by two well-trained dermatologists. when two dermatologists have different scores, the one with the higher score will be included in the statistics
The First Affiliated Hospital with Nanjing Medical University
Other
Analysis of Factors Associated With the Efficacy of 595-nm Pulsed Dye Laser Treatment for Rosacea: A Prospective Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00351897
Cutaneous Dermatophytosis, Pulsed Dye Laser
Tehran, Iran
View Trial DetailsNCT07729540
Erythema, Pathological Conditions, Signs and Symptoms
Sosnowiec, Poland
View Trial DetailsNCT07606820
Rosacea, Skin Diseases
Nanjing, Jiangsu, China
View Trial DetailsNCT04886739
Rosacea, Skin Diseases
Fremont, California, United States
View Trial Details